Study of JANX011 in Healthy Adult Volunteers to Assess Safety and Tolerability.
ConditionAutoimmune
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJanux Therapeutics
About this trial
This first-in-human (FIH) study aims to characterize the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of JANX011 dosed subcutaneously (and potentially intravenously) in healthy adult volunteers (HVs) to gain insight into its therapeutic utility in patients with autoimmune diseases.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy men and women, in the opinion of the PI or designee and as determined by physical examination, laboratory screening tests, and medical history.
Aged 18 to 65 years, with a body weight between 50 to 120 kg and a body mass index (BMI) between 18 to 32 kg/m2 (all inclusive) at Screening.
Able and willing to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.
Disqualifiers
Recent surgery requiring general anesthesia within 12 weeks prior to Screening or is expected to have surgery requiring general anesthesia during the course of the study.
Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), human immunodeficiency virus 1 (HIV-1) or HIV-2 antibodies.
Positive test for tuberculosis (TB) or history of TB (including prior positive interferon gold test result).
Use of any investigational medical device or investigational drug within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to dosing on Day 1.
Trial design
Design model
Sequential
Treatments tested in this trial
JANX011
DrugJANX011 is administered subcutaneously, one time.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Dose EscalationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence, severity, and relatedness of TEAEs, treatment-emergent SAEs, and treatment-emergent AESIs.
Time frame
Up to 85 daysSponsors and contacts
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Source ClinicalTrials.gov