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

Launched by DESIGN THERAPEUTICS, INC. · Jan 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called DT-216P2 to see how safe it is and how the body processes it in healthy adults. The researchers want to understand how different doses of this treatment affect participants when given either through a shot under the skin or directly into the bloodstream. They plan to enroll about 36 participants, and the trial is not yet open for recruiting.

To participate, you need to be between 18 and 45 years old and in good health, which will be determined through various medical checks. It's important that participants are willing to avoid intense exercise during the study and follow specific contraceptive guidelines. If you're interested, the study will help researchers learn more about this potential treatment, but please keep in mind that it’s for healthy individuals and not for those with any serious medical conditions.

Gender

ALL

Eligibility criteria

• 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.