A dose escalation, first-in-human study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of AK120 in healthy subjects and subjects with moderate- to- severe atopic dermatitis
This is a phase 1, randomized, two-part, double-blind, placebo-controlled, dose-escalation, first-in-human study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of AK120 in healthy subjects (part 1, single ascending dose) and subjects with moderate- to- severe atopic dermatitis(part 2, multiple ascending dose)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
80
Single dose of 15mg AK120 or placebo is administered subcutaneously to healthy subjects
Single dose of 50mg AK120 or placebo is administered subcutaneously to healthy subjects
Single dose of 150mg AK120 or placebo is administered subcutaneously to healthy subjects
Emeritus Sydney
Botany, New South Wales, Australia
Emeritus Melbourne
Camberwell, Victoria, Australia
CMAX Clinical Research
Adelaide, Australia
Adverse events(AEs)/serious adverse events(SAEs)
Incidence of treatment emergent adverse events(AEs)/serious adverse events(SAEs)
Time frame: From signing of informed consent through through 12 weeks post-dose
Thymus and activation regulated chemokine (TARC)/Chemokine Ligand 17(CCL17)
Change from baseline in serum levels of thymus activation and regulated chemokine (TARC)/Chemokine Ligand 17 (CCL17) in serum
Time frame: From baseline through 12 weeks post-dose
Maximum observed serum concentration (Cmax)
Maximum observed serum concentration (Cmax) of AK120
Time frame: From baseline through 12 weeks post-dose
Area under the concentration-time curve (AUC)
Area under the concentration-time curve (AUC) of serum concentration of AK120
Time frame: From baseline through 12 weeks postdose
Anti-drug antibodies(ADAs)
Number and percentage of subjects who develop detectable anti-drug antibodies(ADAs)
Time frame: From baseline through 12 weeks postdose
Investigator global assessment (IGA) (part 2)
The proportion of subjects with Investigator global assessment (IGA) 0 to 1 and subjects with IGA reduction from baseline of ≥ 2-point. IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a static 6-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe;5 = very severe) based on erythema and papulation/infiltration.
Time frame: From baseline through 12 weeks postdose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Single dose of 300mg AK120 or placebo is administered subcutaneously to healthy subjects
Single dose of 600mg AK120 or placebo is administered subcutaneously to healthy subjects
Multiple low doses of AK120 or placebo are administered subcutaneously as a weekly dose for a total of four doses to subjects with moderate-to-severe atopic dermatitis
Multiple medium doses of AK120 or placebo are administered subcutaneously as a weekly dose for a total of four doses to subjects with moderate-to-severe atopic dermatitis
Multiple high doses of AK120 or placebo are administered subcutaneously as a weekly dose for a total of four doses to subjects with moderate-to-severe atopic dermatitis
Multiple high doses of AK120 or placebo are administered subcutaneously as a bi-weekly dose for a total of three doses to subjects with moderate-to-severe atopic dermatitis.
Sinclair Dermatology
East Melbourne, Australia
Peninsula Specialist Centre
Kippa-Ring, Australia
Scientia Clinical Research Ltd
Randwick, Australia
Southern Clinical Trials - Waitemata
Birkenhead, Auckland, New Zealand
Optimal Clinical Trials
Auckland, New Zealand
Christchurch Clinical Studies Trust
Christchurch, New Zealand
Southern Clinical Trials - Christchurch
Christchurch, New Zealand
...and 3 more locations
Pruritus-Numeric Rating Scale (P-NRS) (part 2)
The proportion of subjects with Pruritus-Numeric Rating Scale (P-NRS) improvement (reduction) from baseline of ≥ 3-point. Pruritus NRS is an assessment tool that is used to report the intensity of participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 \[0 = no itch; 10 = worst itch imaginable\])
Time frame: From baseline through 12 weeks postdose
Change from baseline in Eczema Area and Severity Index (EASI) score(part 2)
The EASI score was used to measure the severity and extent of atopic dermatitis (AD). The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Time frame: From baseline through 12 weeks postdose
Change from baseline in body surface area (BSA) of AD involvement. (part 2)
Body surface area determined by palm method where 1 palm is equivalent to 1%. Total body surface area ranges from 1% to 100%, with the higher body surface area reflecting the worse severity of AD.
Time frame: From baseline through 12 weeks postdose