Single and Multiple Ascending Dose Study of KN-002

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05006521

Acronym

KN-002

Enrollment

117

Registered

2021-08-16

Start date

2021-07-30

Completion date

2024-07-25

Last updated

2024-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma COPD

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.

Interventions

DRUGKN-002

KN-002 dry powder inhaler

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Safety and tolerability (Parts 1, 2, 3 and 4) via an assessment of the incidence of treatment-related adverse events	Day 1 to 17	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

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026