# First-in-Human Clinical Development of a Novel Drug Candidate with a First-in-Class Mechanism for Smoking Cessation and Abstinence

> **NIH NIH U01** · ASTRAEA THERAPEUTICS, LLC · 2024 · $99,995

## Abstract

ABSTRACT
 The Administrative Supplement requests support for costs arising from unanticipated expenses to conduct
preclinical studies required by the FDA and to be able to continue our Phase 1 single-ascending dose clinical
trial of the novel smoking cessation pharmacotherapy on our current active U01 grant U01DA054882. The
required preclinical studies were not expected and thus not planned for but are now necessary to preserve the
overall impact of the project consistent with its originally approved Specific Aims and overall objectives.
 Our current grant aims to advance the clinical development of a novel smoking cessation
pharmacotherapy into first-in-human (FIH) Phase 1 and early Phase 2A efficacy clinical trials, subsequent to
obtaining FDA approval of the IND for these clinical trials. This novel small-molecule drug candidate is a new
chemical entity with a first-in-class pharmacological mechanism targeting the α3β4 nicotinic acetylcholine
receptor (nAChR) subtype. The objectives of our currently funded grant U01DA054882 are to conduct a Phase
1 single- and multiple-ascending dose (SAD/MAD) FIH trial to assess the safety, tolerability and
pharmacokinetic (PK) profile in humans, and to conduct an efficient Early Phase 2 trial using a crossover
procedure that will provide an early readout of medication efficacy for smoking cessation and a Go/No-go
decision to advance this novel first-in-class candidate to subsequent larger randomized Phase 2 trials.
 As required by the FDA, our experienced drug development team has designed preclinical studies in rat to
address the FDA questions and obtained FDA feedback on the proposed studies to be conducted. The
Administrative supplement requests additional funding for these unanticipated studies, which will allow us to
continue our clinical trial and meet the overall objectives of our grant.

## Key facts

- **NIH application ID:** 10908967
- **Project number:** 3U01DA054882-03S1
- **Recipient organization:** ASTRAEA THERAPEUTICS, LLC
- **Principal Investigator:** KENNETH Alan PERKINS
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $99,995
- **Award type:** 3
- **Project period:** 2021-08-01 → 2024-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10908967

## Citation

> US National Institutes of Health, RePORTER application 10908967, First-in-Human Clinical Development of a Novel Drug Candidate with a First-in-Class Mechanism for Smoking Cessation and Abstinence (3U01DA054882-03S1). Retrieved via AI Analytics 2026-06-12 from https://api.ai-analytics.org/grant/nih/10908967. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*