Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 55 Years|
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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Akesobio Australia Pty Ltd|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Experimental: AK111 30mg
Single dose of 30mg AK111 or placebo is administered subcutaneously to healthy subjects
Experimental: AK111 75mg
Single dose of 75mg AK111 or placebo is administered subcutaneously to healthy subjects
Experimental: AK111 150mg
Single dose of 150mg AK111 or placebo is administered subcutaneously to healthy subjects
Experimental: AK111 300mg
Single dose of 300mg AK111 or placebo is administered subcutaneously to healthy subjects
Experimental: AK111 450mg
Single dose of 450mg AK111 or placebo is administered subcutaneously to healthy subjects
Drug: - AK111 or Placebo
All the subjects in each cohort will be randomized in a 3:1 ratio to receive either AK111 or Placebo.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.