Ph1, Randomized, Double-Blind and Controlled, Dose Escalation and Expansion Study to Assess the Sā¦ (NCT06943378) | Clinical Trial Compass
RecruitingPhase 1
Ph1, Randomized, Double-Blind and Controlled, Dose Escalation and Expansion Study to Assess the Safety and Pharmacokinetics of JST-010 in Healthy Adults
United States104 participantsStarted 2025-05-16
Plain-language summary
The goal of this clinical trial is to learn if a single dose of the study drug, JST-010, is safe and tolerable when administered by injection into the arm or thigh muscle of healthy men and women aged 18 to 55. The main questions it aims to answer are:
* Is a single injection of JST-010 safe?
* What is the concentration of the JST-01 in the blood over time?
* Do antibodies to JST-010 develop following a dose of JST-010?
Researchers will compare JST-010 to Placebo to see if there are any differences in the safety and tolerability of a single dose at different dose levels.
Participants will be confined to the clinic for the first 3 days. They will receive an injection on the second day, and then return for 9 more visits over the period of 1 year for:
* Physical exam with vital signs
* Electro-cardiogram (ECG)
* Bood collection for clinical labs and research samples
* Urine sample
* Assessment of potential adverse effects and medications taken
Who can participate
Age range18 Years ā 55 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Healthy men or women 18 to 55 years of age
ā. BMI between 18 and 32 kg/m2
ā. Negative serum pregnancy test
ā. Use of highly effective birth control method(s) for a minimum of 60 days prior to consent and is willing to continue use for at least 12 months, or abstinence
ā. In good general health as determined by medical history, exams and tests
Exclusion criteria
ā. Acute illness or fever (ā„100.4Ā°F) within 7 days prior to dosing
ā. Any history of receiving treatment, vaccine, or monoclonal antibodies (mAbs) against the Yersinia pestis bacterium
ā. Receipt of any vaccine within 30 days prior to Screening, planned receipt of any vaccine prior to Day 1, or planned receipt of any vaccines before 45 days post-injection.
ā. Any medical condition for which IM injections would be contraindicated in the opinion of the investigator (eg, bleeding disorders, anticoagulant therapy, and severe thrombocytopenia)
What they're measuring
1
Safety and tolerability of a single dose of JST-010 when administered intramuscularly (IM) in healthy adults
Timeframe: 1) Local and systemic solicited AES from injection to Day 7, 2) All AEs post-injection to final visit at Week 48, 3) SAEs, MAAEs, and AESIs post-injection to final visit at Week 48
ā. History of congenital or acquired immunodeficiency syndrome
ā. Prior solid organ or bone marrow transplant
ā. Use of systemic steroids, immunosuppressive agents, anticoagulants, or antiarrhythmics within 1 year prior. A single short course (ie, less than 14 days) is allowed provided it is concluded more than 6 months prior to Screening
ā. Upper arm is with insufficient muscular tissue for IM injections or is obscured by tattoos or rash that may preclude accurate assessment of injection site reactions