Single and Multiple Ascending Dose Study of KN-002

Asthma COPD Clinical Trial

— KN-002  

Official title:

Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, PK, and PD of Single Ascending Doses of KN-002 in Healthy Subjects and Multiple Ascending Doses of KN-002 in Subjects With Mild Asthma, Moderate-Severe Asthma and COPD

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05006521
• Other study ID #: KN-002/1/001
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 30, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: January 2024
• Source: Kinaset Therapeutics Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 117
• Est. completion date: April 30, 2024
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma COPD

Intervention

Drug:
• KN-002
KN-002 dry powder inhaler

Locations

Country	Name	City	State
United Kingdom	Medicines Evaluation Unit	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Kinaset Therapeutics Inc

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetics (Parts 1, 2, 3 and 4) via the determination of area under the curve (AUC)	KN-002 pharmacokinetics after single and repeat dosing to healthy volunteers and patients with mild asthma, moderate to severe asthma and COPD:	Day 1 to 17
Secondary	Pharmacokinetics (Parts 1, 2, 3 and 4) via the determination of maximum plasma concentrations (Cmax)	KN-002 pharmacokinetics after single and repeat dosing to healthy volunteers and patients with mild asthma, moderate to severe asthma and COPD:	Day 1 to 17
Secondary	Pharmacodynamics (Parts 2, 3 and 4) via changes in fractional exhaled nitric oxide (FeNO) levels	Change of fractional exhaled nitric oxide (FeNO) levels after repeated dosing to patients with mild asthma, moderate to severe asthma and COPD	Day 1 to 17