Study of SRK-439 in Healthy Adults
This study is testing a drug called SRK-439 in healthy adults. It's designed to see how safe SRK-439 is and how well your body tolerates it when given as a single dose or multiple doses under the skin (subcutaneous administration). Researchers will also look at how the drug moves through your body and what effects it has. You might receive SRK-439 or a placebo (an inactive substance that looks like the drug). This study is looking for healthy adults between 18 and 55 years old with a body mass index (BMI) between 18 and 35. The main goal is to check safety and tolerability over a period of up to 32 weeks.
- Study design
- This is an interventional study involving 76 healthy adult participants. It will test single and multiple doses of SRK-439, or a placebo.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety and tolerability for up to 32 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Single- and Multiple-Ascending Dose Study of SRK-439 in Healthy Adults
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participantsUp to 32 weeks
• Incidence of AEs
- Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participantsUp to 32 weeks
• Incidence of SAEs
- Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participantsUp to 32 weeks
Changes from baseline in clinical safety laboratory tests (serum chemistry)
- Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participantsUp to 32 weeks
Changes from baseline in clinical safety laboratory tests (hematology)
- Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participantsUp to 32 weeks
Changes from baseline in clinical safety laboratory tests (urinalysis)
- Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participantsUp to 32 weeks
Changes from baseline in clinical safety laboratory tests (coagulation assessments)
- Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participantsUp to 32 weeks
Changes from baseline in vital signs (heart rate) measured in bpm
- Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participantsUp to 32 weeks
Changes from baseline in vital signs (blood pressure) measured in mmHg
- Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participantsUp to 32 weeks
Changes from baseline in vital signs (respiratory rate) measured in rpm
- Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participantsUp to 32 weeks
Changes from baseline in vital signs (body temperature) measured in Celsius
- Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participantsUp to 32 weeks
Changes from baseline in ECG measurements