Single and Multiple Ascending Dose Study of KN-002

NCT05006521 | Completed Phase 1

• 1 other identifier: KN-002/1/001
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma COPD

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability (Parts 1, 2, 3 and 4) via an assessment of the incidence of treatment-related adverse events

  To assess the safety and tolerability of KN-002 via the assessment of the number, severity and type of treatment emergent adverse events post single and repeat dose administration to healthy volunteers and patients with mild asthma, moderate to severe asthma and COPD

  Day 1 to 17

Secondary Outcomes (3)

• Pharmacokinetics (Parts 1, 2, 3 and 4) via the determination of area under the curve (AUC)

  Day 1 to 17

• Pharmacokinetics (Parts 1, 2, 3 and 4) via the determination of maximum plasma concentrations (Cmax)

  Day 1 to 17

• Pharmacodynamics (Parts 2, 3 and 4) via changes in fractional exhaled nitric oxide (FeNO) levels

  Day 1 to 17

Study Arms (8)

KN-002 for SAD (Part 1)

EXPERIMENTAL

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

Drug: KN-002

Placebo for SAD (Part 1)

PLACEBO COMPARATOR

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

Drug: KN-002

KN-002 for MAD (Part 2)

EXPERIMENTAL

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

Drug: KN-002

Placebo for MAD (Part 2)

EXPERIMENTAL

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

Drug: KN-002

KN-002 for Part 3

EXPERIMENTAL

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

Drug: KN-002

Placebo for Part 3

EXPERIMENTAL

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

Drug: KN-002

KN-002 for Part 4

EXPERIMENTAL

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

Drug: KN-002

Placebo for Part 4

EXPERIMENTAL

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

Drug: KN-002

Interventions

KN-002 DRUG

KN-002 dry powder inhaler

KN-002 for MAD (Part 2); KN-002 for Part 3; KN-002 for Part 4; KN-002 for SAD (Part 1); Placebo for MAD (Part 2); Placebo for Part 3; Placebo for Part 4; Placebo for SAD (Part 1)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kinaset Therapeutics Inc: lead

Study Sites (1)

Medicines Evaluation Unit

Manchester, M23 9QZ, United Kingdom

Location

Study Officials

• Dave Singh

  Medicines Evaluation Unit

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 16, 2021
• Study Start: July 30, 2021
• Primary Completion: December 20, 2023
• Study Completion: July 25, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)