Ph1, Randomized, Double-Blind and Controlled, Dose Escalation and Expansion Study to Assess the Safety and Pharmacokinetics of JST-010 in Healthy Adults

NCT06943378 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: DDF3-CL101MCDC No. W15QKN-16-9-1002
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pre-exposure Prophylaxis Against Pneumonic Plague in Healthy Adults

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of a single dose of JST-010 when administered intramuscularly (IM) in healthy adults

  1. Incidence of solicited local (injection site) and systemic AEs post-injection through Day 7 (with the inpatient and outpatient participant diaries being collected on Day 3 and Day 8, respectively). 2. Incidence of unsolicited AEs through end of study (EOS). 3. Incidence of SAEs, medically attended AEs (MAAEs), and AEs of special interest (AESIs) post-injection through EOS.

  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

Secondary Outcomes (10)

• Pharmacokinetic Cmax of JST-010

  From enrollment to the end of study at 48 weeks

• Pharmacokinetic Tmax of JST-010

  From enrollment to the end of study at 48 weeks

• Pharmacokinetic Tlast of JST-010

  From enrollment to the end of study at 48 weeks

• Pharmacokinetic AUC0-D85 of JST-010

  From enrollment to the end of study at 48 weeks

• Pharmacokinetic AUC0-t of JST-010

  From enrollment to the end of study at 48 weeks

Study Arms (2)

JST-010: The active investigational product

ACTIVE COMPARATOR

Biological: Monoclonal antibody JST-010

JST-012 Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Monoclonal antibody JST-010 BIOLOGICAL

Active study drug

JST-010: The active investigational product

Placebo DRUG

Placebo

JST-012 Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men or women 18 to 55 years of age
• BMI between 18 and 32 kg/m2
• Negative serum pregnancy test
• 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
• In good general health as determined by medical history, exams and tests

You may not qualify if:

• Acute illness or fever (≥100.4°F) within 7 days prior to dosing
• Any history of receiving treatment, vaccine, or monoclonal antibodies (mAbs) against the Yersinia pestis bacterium
• 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.
• Any medical condition for which IM injections would be contraindicated in the opinion of the investigator (eg, bleeding disorders, anticoagulant therapy, and severe thrombocytopenia)
• History of congenital or acquired immunodeficiency syndrome
• Prior solid organ or bone marrow transplant
• 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
• 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
• Use of any medications started within 30 days prior to Day -1, including prescription medications, nutritional supplements, and over-the-counter medications
• Vitamin supplements are allowed
• Recommended doses of acetaminophen are allowed, except for 24 hours prior to dosing
• Recommended doses of non-steroidal anti-inflammatory drugs (NSAIDs) (eg, aspirin, ibuprofen) are also allowed, except for 7 days prior to dosing
• Positive human immunodeficiency virus (HIV-1/-2) antibody result by history or at Screening
• Positive hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C antibody
• Positive urine drug test or cotinine (indicating active current smoking) at Screening or Day -1, positive alcohol breath test at Screening or on Day -1, or suspected/known drug abuse and/or alcohol use disorder

Sponsors & Collaborators

• Just-Evotec Biologics: lead

Study Sites (1)

PPD Las Vegas Clinical Research Unit

Las Vegas, Nevada, 89113, United States

RECRUITING

Central Study Contacts

Dennis Miller, PhD

CONTACT

(206) 651-5094; jeb.clinicaltrials@evotec.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor and CRO
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-blinded, Placebo controlled

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 24, 2025
• Study Start: May 16, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: June 8, 2025

Record last verified: 2025-05

Locations

US (1)