A Phase 1, First-in-Human Study of CND319 in Healthy Participants and Patients With Rheumatic Diseases
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCandid Therapeutics
About this trial
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical activity of CND319 in healthy adult participants and patients with rheumatic diseases.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18 to 65 years old
Body mass index 18-30 kg/m2 and weight 55-100 kg
Individuals in good health
Agree to abstain from consumption of alcohol 48 hours prior to study visits
Disqualifiers
Inadequate clinical laboratory parameters at Screening
Active infection
Receipt of or inability to discontinue any excluded therapies
Individuals with immediate household contact with your children (eg, ≤ 6 years old) or immunocompromised persons
Trial design
Design model
Single group
Treatments tested in this trial
CND319
Biological/VaccineCND319
Treatment groups
105 Participants
are divided into 1 treatment groupGroup A: CND319Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence proportion and severity of treatment-emergent adverse events through end of study
Time frame
Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)2
Changes to body temperature
oral, tympanic, or axillary
Time frame
Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)3
Changes to heart rate
Time frame
Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)4
Changes to respiratory rate
Time frame
Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)Secondary outcomes
1
PK parameters for CND319: Maximum observed concentration (Cmax)
Time frame
Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)2
PK parameters for CND319: Time to maximum observed concentration (Tmax)
Time frame
Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)3
PK parameters for CND319: Area under the concentration-time curve (AUC)
Time frame
Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)4
PK parameters for CND319: Apparent clearance (CL/F)
Time frame
Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)Sponsors and contacts
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Source ClinicalTrials.gov