Psoriasis
Conditions
Brief summary
This is a Phase 1, randomized, double-blind, placebo-controlled, single dose-escalation first-in human study to evaluate the safety, tolerability, PK, PD and immunogenicity of AK111 in healthy subjects following SC administration. The study will consist of cohorts of healthy subjects. Cohort 1, four unique subjects will be randomized to receive either active AK111 (N=3) or matching placebo (N=1). Cohorts 2, 3, 4 and 5, eight unique subjects will be randomized to receive either active AK111 (N=6) or matching placebo (N=2). Approximately 36 subjects will be treated in this study.
Interventions
DRUGAK111 or Placebo
All the subjects in each cohort will be randomized in a 3:1 ratio to receive either AK111 or Placebo.
Sponsors
Akesobio Australia Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects must meet all of the following inclusion criteria (as applicable) to be eligible for participation in this study. 1. Have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures. 2. Female or male between 18 and 55 years of age, inclusive, at screening. 3. Must have a calculated body mass index (BMI) 19 ≤ BMI ≤ 32(inclusive) at screening, and a total body weight ≥ 50 kg for male or ≥ 45 kg for female at screening. 4. Females of child bearing potential must have a negative pregnancy test in serum at screening and a negative serum pregnancy test on Day -1, either be of non-child bearing potential, defined as being: 1. Postmenopausal (for at least 2 years before screening), verified by serum follicle stimulating hormone (FSH) level \>40 mIU/mL at screening, or 2. Permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy), or 3. Congenitally sterile 5. Women of child-bearing potential must use one of the following methods of contraception, from screening until at least 120 days after dosing: A highly effective method with a failure rate of less than 1%: * Implant contraceptive (e.g. Jadelle) * Intra-uterine device (IUD) containing either copper or levonorgestrel (e.g. Mirena) * Male sterilization (vasectomy) * Female sterilization (e.g. by bilateral tubal ligation ('tying tubes') or hysterectomy) A method for which the failure rate is between 5% and 10% in real life use, in combination with a barrier method (male condom): * Injectable contraceptive (e.g. Depo Provera) * Oral Contraceptive Pill (combined hormonal pill or progestogen-only 'mini-pill') * Vaginal contraceptive ring (e.g. NuvaRing) Please note that condoms alone are not highly effective methods of contraception. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. 6. Nonsterilized male subjects who are sexually active with a female partner of childbearing potential must use an effective method of contraception as listed above from Day 1 through 120 days after receipt of the last dose of study medication. It is strongly recommended for the female partner of a male subject to also us an effective method of contraception throughout this period. 7. Must, in the opinion of the Investigator, be in good general health based upon medical history, physical examination (including vital signs), 12-lead ECG and clinical laboratory tests must fall within the clinical laboratory's reference normal ranges unless the results have been determined by the Investigator to have no clinical significance). 8. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures as specified in the protocol.
Exclusion criteria
Subjects who meet any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment emergent AE/SAEs | From baseline through 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The endpoint for assessment of PD including the change from baseline in serum IL-17A level and serum cytokines. | From baseline through 12 weeks |
| Area under the concentration curve (AUC) of AK111 | From baseline through 12 weeks |
| Maximum observed concentration (Cmax) of AK111 | From baseline through 12 weeks |
| Number of subjects who develop detectable anti-drug antibodies (ADAs) [ | From baseline through 12 weeks |
Countries
New Zealand
Outcome results
None listed