Single and Multiple Ascending Dose Study of KN-002

Kinaset Therapeutics

Status and phase: Completed; Phase 1

Conditions: Asthma COPD

Treatments: Drug: KN-002

Study type: Interventional

Funder types: Industry

Identifiers

NCT05006521

KN-002/1/001

Details and patient eligibility

About

This is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists of 4 parts: Part 1 is a single ascending dose (SAD) study in healthy volunteers; Part 2 is a multiple ascending dose (MAD) study in subjects with stable, mild asthma; Part 3 is a repeat dose in patients with moderate to severe asthma and Part 4 is a repeat dose in patients with COPD.

Enrollment: 117 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female, 18 - 55 years old
• Willing and able to give informed consent and comply with the study
• Body mass index (BMI) 18 to 32 kg/m2 and weighs at least 50 kg
• Women of child bearing potential must have a negative pregnancy test and use a highly efficient birth control method
• Pre-bronchodilator FEV1 ≥ 70 and ≥80% for Part 1 and Part 2 participants, respectively
• Pre-Bronchodilator FEV1 ≥50% predicted and ≤100% for Part 3
• Post Bronchodilator FEV1 ≥40 and ≤ 85% for Part 4

Exclusion criteria

• Clinically significant laboratory test abnormalities
• Clinically significant abnormal blood pressure and/or pulse rate
• Resting ECG clinically significant abnormalities
• Respiratory tract infection within 6 weeks of screening
• Positive test for active COVID-19 within 2 days prior to administration of IMP

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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117 participants in 8 patient groups, including a placebo group

KN-002 for SAD (Part 1)

Experimental group

Description:

Up to 6 cohorts with 6 of 8 subjects per cohort randomised to receive KN-002

Treatment:

Drug: KN-002

Placebo for SAD (Part 1)

Placebo Comparator group

Description:

Up to 6 cohorts with 2 of 8 subjects per cohort randomised to receive placebo

Treatment:

Drug: KN-002

KN-002 for MAD (Part 2)

Experimental group

Description:

Up to 4 cohorts with 6 of 8 subjects per cohort randomised to receive KN-002

Treatment:

Drug: KN-002

Placebo for MAD (Part 2)

Experimental group

Description:

Up to 4 cohorts with 2 of 8 subjects per cohort randomised to receive placebo

Treatment:

Drug: KN-002

KN-002 for Part 3

Experimental group

Description:

Single cohort with up to 18 of 24 subjects randomised to active treatment

Treatment:

Drug: KN-002

Placebo for Part 3

Experimental group

Description:

Single cohort with up to 6 of 24 subjects randomised to placebo treatment

Treatment:

Drug: KN-002

KN-002 for Part 4

Experimental group

Description:

Single cohort with up to 18 of 24 subjects randomised to active treatment

Treatment:

Drug: KN-002

Placebo for Part 4

Experimental group

Description:

Single cohort with up to 6 of 24 subjects randomised to placebo treatment

Treatment:

Drug: KN-002