ClinicalTrials.gov record NCT06772870

A Single Ascending Dose Study of DT-216P2 in Normal Healthy Participants

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 7, 2026

A Phase 1, Double-Masked, Randomized, Placebo-Controlled, Single Ascending Dose Crossover Study to Assess the Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Intravenous DT-216P2 in Normal Healthy Participants

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age18 years old to 45 years old
SexAll
LocationAustralia
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 1 study will evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of DT-216P2 given subcutaneously or intravenously. It is randomized, double-masked, placebo-controlled and uses a crossover design in about 36 normal healthy participants. The study enrolls healthy adults aged 18 to 45.

What it is studying. The study tests the safety and tolerability of single ascending doses of DT-216P2 and measures how the drug behaves in the body (pharmacokinetics) when given subcutaneously or intravenously to healthy adults.

What the researchers hope to learn. To evaluate safety and tolerability of single ascending doses of DT-216P2 and to measure pharmacokinetic parameters (Cmax, Tmax, AUC) in healthy participants.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

This purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of DT-216P2 administered either subcutaneously (SC) and intravenously (IV) in normal healthy participants. Approximately 36 participants will be enrolled into this study.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • DT-216P2
  • Saline

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Participants must be 18-45 years of age inclusive, at the time of signing the informed consent.
  • Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG.
  • Agree to abstain from strenuous physical activity outside of daily norm, until end of study.
  • Body mass index between 16 and 32 kg/m2 (inclusive) at screening; weight should be <= 100 kg at screening.
  • Male and/or female using protocol defined and regulatory approved contraception.
  • Capable of giving signed informed consent.

Exclusion criteria

  • Any concomitant medical condition that in the opinion of the investigator, puts the participant at risk or precludes participant from completing the study protocol.
  • Any clinically significant nonmedical conditions and psychiatric disorders that could put the participant at higher risk for participation in the study, influence the participant's ability to participate in the study, or interfere with interpretation of the participant's study results, in the opinion of the investigator.
  • Is not willing to comply with the contraceptive requirements during the study period, as per protocol.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

After screening and consent, participants receive a single ascending dose of DT-216P2 or saline placebo given as a subcutaneous injection, subcutaneous infusion, or intravenous infusion (study uses randomized, double-masked, crossover assignment). Blood samples for drug levels and safety checks will be taken before dosing and for up to about 240 hours after dosing, and safety will be monitored through follow-up to about Day 30 after the first dose. Participants must follow contraception and activity restrictions stated by the study and complete scheduled exams, ECGs, and lab tests. Specific visit numbers, timing, and other procedures are not detailed in the registry record.

How the study is structured. Phase 1 interventional trial. Participants are randomized and double-masked to receive DT-216P2 or saline placebo in a placebo-controlled crossover design. Single ascending doses will be given by subcutaneous injection, subcutaneous infusion, or intravenous infusion; participants are followed for safety and blood sampling for pharmacokinetics.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in Australia. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

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Important dates

Study start
February 2025 (estimated)
Primary completion
September 2025 (estimated)
Study completion
December 2025 (estimated)
Target enrollment
36 participants (estimated)
Last updated on registry
Feb 21, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Design Therapeutics, Inc.

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

pharmacokinetics
How the body absorbs, distributes, breaks down and removes a drug. It is studied by measuring drug levels or related substances at set times after a dose.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
ECG
A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
at screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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