None listed
Conditions
Brief summary
This is a FIH randomized, double-blind, placebo-controlled study of the safety, tolerability, PK, and PD following single and multiple intravenously or subcutaneous doses of CLD-423 in healthy adult participants
Interventions
This is a first-in-human (FIH) randomized, double-blind, placebo-controlled study of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) following single and multiple intravenous or subcutaneous doses of CLD-423 in healthy adult participants.
The study will be conducted as two parts:
Part 1: Single-Ascending Dose
Up to approximately 48 healthy male or female participants will be enrolled in one of six single-dose cohorts in a dose-ascending manner. Each cohort will consis
This is a first-in-human (FIH) randomized, double-blind, placebo-controlled study of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) following single and multiple intravenous or subcutaneous doses of CLD-423 in healthy adult participants. The study will be conducted as two parts: Part 1: Single-Ascending Dose Up to approximately 48 healthy male or female participants will be enrolled in one of six single-dose cohorts in a dose-ascending manner. Each cohort will consist of eight eligible participants randomized to CLD-423 or placebo in a 3:1 ratio (six participants receiving a single dose of CLD-423 and two receiving placebo). CLD-423 will be administered either intravenously (IV infusion) or subcutaneously (SC injection) depending on the cohort. Dosing will be fully supervised onsite in the clinical unit to ensure adherence, and participants will reside at the clinic for 5 days post-dose. Part 2: Multiple-Ascending Dose Part 2 will begin only after Part 1 Cohorts S3 and S4 have completed and safety and PK data have been reviewed by the SRC, typically after at least 14 days of safety and 7 days of PK data availability. Up to 32 healthy adults will be enrolled in four cohorts (M1-M4) in a dose-ascending manner, with unique participants enrolled for Part 2 (participants from Part 1 will not roll over). Each participant will receive three doses of CLD-423 or placebo, given once every 4 weeks (Day 1, Day 29, and Day 57), and dosing will be supervised onsite. The starting dose in Part 2 will not exceed the highest dose tested in Part 1, and placebo will be included in all MAD cohorts. Participants will stay in the unit for 5 days for the first dose and 3 days each for the second and third doses.
Sponsors
Novotech (Australia) Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Is capable, in the Investigator’s judgement, of comprehending the study requirements and providing written informed consent, indicating their willingness and ability to adhere to protocol requirements, as laid out in the informed consent form (ICF). 2. Is between 18 to 65 years of age inclusive at the time of signing the ICF. 3. Is male or female, who is in apparent good health, as confirmed by a comprehensive medical evaluation, including medical history, physical examination, vital signs, laboratory assessments, and 12 lead ECG. 4. Has a body mass index between 18 and 32 kg/m2 inclusive, and a total body weight of 50 kg (110 lb). 5. Has agreed to follow the protocol’s contraceptive guidance.
Exclusion criteria
1. Has been previously enrolled and treated in any part of this study. 2. Has a history or evidence of any clinically significant hematological, renal, immunological, endocrine (including diabetes), pulmonary, metabolic, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disorder (including drug allergies) except for untreated, asymptomatic seasonal allergies present at the time of dosing. 3. Has or tests positive for Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV) at screening, as per local regulations. 4. Has a Quantiferon Gold positive test for tuberculosis at screening. 5. Has a history or current herpes simplex and herpes zoster at screening. 6. Has had an infection. 7. Has a history or current condition (including laboratory abnormalities) that might confound the interpretation of the results of this study, effect the participant’s involvement in the study, or is not in the best interest of the participant, in the opinion of the Investigator. 8. Has a history of hypersensitivity to biological drugs. 9. Is taking prohibited products. 10. Has received an investigational product (drug or vaccine) within 30 days or 5 into half life of the investigational product preceding the first dose of CLD 423/placebo (whichever is longer). 11. Has a BP greater than 140 mm Hg (systolic) or more than 90 mm Hg (diastolic), following at least 5 minutes of rest in semi-recumbent position. If BP is greater 140 mm Hg (systolic) or more than 90 mm Hg (diastolic), the BP measurement should be repeated twice and the average of the three BP values should be used to determine the participant's eligibility. 12. Has a standard 12 lead ECG that demonstrates clinically significant abnormalities that may affect participant safety or interpretation of study results including QT interval with Fridericia’s correction method (QTcF) more than 450 ms (males) or more than 470 ms (females) or PR outside the range of 120 to 220 ms, confirmed by triplicate ECG readings with average of the three readings recorded as Screening and Check-in (Day -1) value. Each ECG assessment must be separated by 1 to 2 minutes, within an overall 5 minute window, as per industry standards. Entry of any participant with an abnormal (non-clinically significant) ECG must be approved and documented by signature of the Investigator. 13. Has abnormal laboratory values that suggest a clinically significant underlying disease or a participant with ANY of the following abnormalities in clinical laboratory tests, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary: a. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level greater than 1.5 into upper limit of normal (ULN) b. Total bilirubin level more than 1.5 into ULN 14. Has a history of drug or alcohol abuse and/or any other illicit drug use or: a. Dependence within 1 year prior to the Screening Visit or is unwilling to agree to abstain from alcohol and drugs throughout the study treatment period to 7 days after last administration of CLD-423/placebo. b. A positive urine test for drugs of abuse during screening or at Check-in (Day -1). NOTE: a repeat test during screening period is permitted. c. A history of regular heavy smoking 10 cigarettes per day or similar for vaping or cumulative lifetime use exceeding 10 pack-years or has a positive urine cotinine test at Check-in (Day -1). Occasional cigarette/vape users up to two per day or five to 10 per week is permitted, but participants must agree to refrain from cigarette/vape use from 48 hours before Check-in (Day -1), for the duration of the study treatment period, to 7 days after last dose of CLD-423/placebo). 15. Has donated or lost 450 mL or more of their blood volume (including plasmapheresis) or had a transfusion of any blood product within 30 days prior to Day 1. 16. Is pregnant, based upon a serum test at screening and urine test at Check-in (Day 1), or is breastfeeding. 17. Is planning on starting a family during the treatment and follow-up period.
Outcome results
None listed