Phase 1 Study on the Safety, Tolerability, and Pharmacokinetics of JST-018 in Healthy Adults

NCT07595458 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: DDF4-CL101MCDC No. W15QKN-16-9-1002
• Study Type: interventional
• Target: 48
• 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-018, 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 administration of JST-018 safe?
• What is the concentration of the JST-018 in the blood over time?
• Do antibodies to JST-018 develop following a dose of JST-018? Researchers will compare JST-018 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

Antiviral Drug

Outcome Measures

Primary Outcomes (6)

• Safety and tolerability of of JST-018 administered intramuscularly (IM)

  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)

  From injection to Day 7

• Safety and tolerability of of JST-018 administered IM

  Incidence of unsolicited AEs through end of study (EOS)

  From injection to final visit at Week 48

• Safety and tolerability of of JST-018 administered IM

  Incidence of SAEs, medically attended AEs (MAAEs), and AEs of special interest (AESIs)

  From injection to final visit at Week 48

• Safety and tolerability of of JST-018 administered IM

  Incidence of Clinically Significant Changes in Laboratory Values

  From injection to final visit at Week 48

• Safety and tolerability of JST-018 administered as IM

  Incidence of Clinically Significant Changes in Vital Sign Measurements

  From injection to final visit at Week 48

• Safety and tolerability of JST-018 administered as IM

  Incidence of Clinically Significant Changes in ECG results

  From injection to final visit at Week 48

Secondary Outcomes (10)

• Pharmacokinetic Cmax of JST-018

  From enrollment to the end of study at 48 weeks

• Pharmacokinetic Tmax of JST-018

  Time Frame: From enrollment to the end of study at 48 weeks

• Pharmacokinetic Tlast of JST-018

  From enrollment to the end of study at 48 weeks

• Pharmacokinetic AUC0-t of JST-018

  From enrollment to the end of study at 48 weeks

• Pharmacokinetic AUC0-inf of JST-018

  From enrollment to the end of study at 48 weeks

Study Arms (2)

JST-018 Investigational Product

ACTIVE COMPARATOR

Biological: JST-018 combination of 3 monoclonal antibodies

JST-017 Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

JST-018 combination of 3 monoclonal antibodies BIOLOGICAL

Monoclonal antibodies

JST-018 Investigational Product

Placebo DRUG

Placebo Comparator

JST-017 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 smallpox, monkeypox, or other orthopox viruses.
• 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, , including positive human immunodeficiency virus (HIV-1/-2) antibody result
• Prior solid organ or bone marrow transplant
• Clinically significant corneal or lens abnormality as determined by history, clinical examination, or diagnostic imaging. Including, but not limited to:
• Corrected vision of less (worse) than 20/40
• History of any clinically significant history of eye trauma, in the opinion of the investigator
• History of cataracts or current cataracts
• Lens opacity greater than NC2, C2, or P0 as determined by the Lens Opacities Classification System (LOCS) III
• History of uveitis (including acute)
• Use of ocular or inhaled prescription steroids within 1 year prior to Screening nasal steroids are permissible). A single short course (ie, less than 14 days) of systemic steroid therapy is allowed provided it is concluded more than 6 months prior to Screening.
• History of diabetes
• Use of immunosuppressive agents, anticoagulants, or antiarrhythmics within 1 year prior to Screening. Nasal steroid use is permissible.

Sponsors & Collaborators

• Just-Evotec Biologics: lead

Study Sites (1)

PPD Las Vegas Clinical Research Unit

Las Vegas, Nevada, 89113, United States

Location

Central Study Contacts

Nels Royer

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: May 7, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): June 11, 2026
• Primary Completion (Estimated): November 9, 2026
• Study Completion (Estimated): October 4, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)