A Study of AK111 in Healthy Subjects

NCT03622021 | Completed Phase 1

• 1 other identifier: AK111-101
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment emergent AE/SAEs

  From baseline through 12 weeks

Secondary Outcomes (4)

• 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

Study Arms (6)

AK111 30mg

EXPERIMENTAL

Single dose of 30mg AK111 or placebo is administered subcutaneously to healthy subjects

Drug: AK111 or Placebo

AK111 75mg

EXPERIMENTAL

Single dose of 75mg AK111 or placebo is administered subcutaneously to healthy subjects

Drug: AK111 or Placebo

AK111 150mg

EXPERIMENTAL

Single dose of 150mg AK111 or placebo is administered subcutaneously to healthy subjects

Drug: AK111 or Placebo

AK111 300mg

EXPERIMENTAL

Single dose of 300mg AK111 or placebo is administered subcutaneously to healthy subjects

Drug: AK111 or Placebo

AK111 450mg

EXPERIMENTAL

Single dose of 450mg AK111 or placebo is administered subcutaneously to healthy subjects

Drug: AK111 or Placebo

AK111 600mg

EXPERIMENTAL

Single dose of 600mg AK111 or placebo is administered subcutaneously to healthy subjects

Drug: AK111 or Placebo

Interventions

AK111 or Placebo DRUG

All the subjects in each cohort will be randomized in a 3:1 ratio to receive either AK111 or Placebo.

AK111 150mg; AK111 300mg; AK111 30mg; AK111 450mg; AK111 600mg; AK111 75mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures.
• Female or male between 18 and 55 years of age, inclusive, at screening.
• 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.
• 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:
• Postmenopausal (for at least 2 years before screening), verified by serum follicle stimulating hormone (FSH) level \>40 mIU/mL at screening, or
• Permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy), or
• Congenitally sterile
• 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)

You may not qualify if:

• Subjects who are investigational site staff members or subjects who are Sponsor employees directly involved in the conduct of the study.
• Are pregnant, nursing, or planning pregnancy within 120 days following the last dose of study medication (both men and women) while enrolled in the study.
• Have previously participated in an investigational trial involving administration of any investigational compound within 3 months or 5 half-lives (whichever is longer) prior to the study dosing, or currently participating in another clinical study.
• Have a planned surgical intervention for a pretreatment condition within the duration of the trial, including the follow up period.
• Have used any biologic within the previous 12 months prior to the study dosing.
• Use of any of the following, unless agreed as non-clinically relevant by the Investigator: Prescription medication within 4 weeks prior to the study dosing; Over-the-counter medication (excluding paracetamol) within 7 days prior to the study dosing. Paracetamol use must be limited to 2 g per day and no more than 3 days usage in the 4 weeks prior to the study dosing; Vitamin therapy or dietary supplements within 7 days prior to the study dosing and for the duration of the study; Herbal supplements within 4 weeks prior to the study dosing and for the duration of the study. Medications which are known CYP P450 isoenzyme substrates/inducers/inhibitors must be excluded within 4 weeks prior to study dosing and for the duration of the study.
• Current acute infection or history of acute infection within 7 days prior to receipt of the study drug; additionally, aural temperature that exceeds 37.4°C at Day -1 (baseline).
• Have had a serious infection, define as requiring intravenous antibiotics or hospitalization within 3 months prior to screening; Have had recurrent or chronic infection, define as ≥ 3 infections requiring anti-microbials over the past 12 months prior to screening.
• Have a history of latent or active granulomatous infection, including histoplasmosis, candidiasis (clinically significant candidiasis or recurrent candidiasis), or coccidioidomycosis prior to screening, or a history of any other infectious disease within 4 weeks prior to screening that in the opinion of the investigator, affects the subject's ability to participate in the trial.
• History or complication of tuberculosis, or evidence of latent tuberculosis by QuantiFERON screening. If the QuantiFERON®-TB Gold test is indeterminate, a retest is allowed if results can be obtained. If the retest is also indeterminate, the subject will be excluded from the study. Subjects who have had household contact with a person with active TB are excluded.
• Positive for hepatitis B surface antigen, hepatitis C antibodies or HIV at screening.
• Have had a substance abuse (drug or alcohol) problem within the previous 3 years, or a positive urine drug screen at screening.
• History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 100 mL of wine or 360 mL of beer or 45 mL of hard liquor) within 6 months of screening.
• Use of tobacco or nicotine containing products (including e-cigarettes) at any time within six months before screening and for the duration of the study.
• Have poor venous access and are unable to donate blood.

Sponsors & Collaborators

• Akesobio Australia Pty Ltd: lead

Study Sites (1)

Christchurch Clinical Studies Trust (CCST)

Christchurch, 8140, New Zealand

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 9, 2018
• Study Start: August 14, 2018
• Primary Completion: September 9, 2019
• Study Completion: September 9, 2019
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)