A Single Ascending Dose Study of DT-216P2 in Normal Healthy Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DT-216P2, Saline.
- Who it may be relevant to
- Registry conditions: Friedreich Ataxia. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Drug DT-216P2
DT-216P2 will be administered as subcutaneous injection, subcutaneous infusion and intravenous infusion. - Drug Saline
Normal saline solution will be used as placebo control.
Primary outcome measures
- Frequency of treatment emergent adverse events (TEAEs) [Time frame: From first dose to end of study, Day 30 post first dose administration.]
Secondary outcome measures (3)
- Maximum Plasma Concentration (Cmax) of DT-216P2 [Time frame: Pre-dose and up to 240 hours post first dose for both SC and IV infusion.]
- Time to Maximum Plasma Concentration (Tmax) of DT-216P2 [Time frame: Pre-dose and up to 240 hours post first dose for both SC and IV infusion.]
- Area Under the Concentration-time Curve (AUC) of DT-216P2 [Time frame: Pre-dose and up to 240 hours post first dose for both SC and IV infusion.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Australia · 1 center
- Nucleus Network, Level 5, 89 Commercial Road — Melbourne
Identifiers
NCT: NCT06772870 · DTX-216P2-011