Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ATTO-1310 · 1 trial · 4 indications
The primary analysis will describe the incidence of AEs and laboratory abnormalities. AEs will be coded according to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA, version 26.1 or the current version). Their severity will be graded using the NCI CTCAE v5.0 or the current version.
Clinical laboratory parameters (hematologic and blood chemistry) will be summarized for each post-baseline visit.
ECG findings (including QT abnormalities) will be summarized for each post-baseline visit.
Vital signs (systolic and diastolic blood pressure, temperature, heart rate) will be summarized for each post-baseline visit.
| Arm | Type | Description |
|---|---|---|
| ATTO-1310 single dose IV | EXPERIMENTAL | ATTO-1310 Attobody Dose level cohorts receiving a single dose IV |
| ATTO-1310 Placebo single dose IV | PLACEBO_COMPARATOR | Placebo preparation to match Experimental Arm with single dose IV |
| ATTO-1310 single dose SC | EXPERIMENTAL | ATTO-1310 Attobody Dose level cohorts receiving a single dose SC |
| ATTO-1310 Placebo single dose SC | PLACEBO_COMPARATOR | Placebo preparation to match Experimental Arm with single dose SC |
| ATTO-1310 multiple dose SC | EXPERIMENTAL | ATTO-1310 Attobody administered to dose level cohorts in multiple SC doses |
| ATTO-1310 Placebo multiple dose SC | PLACEBO_COMPARATOR | Placebo preparation to match Experimental Arm administered in multiple SC doses |
| Name | Type | Description |
|---|---|---|
| ATTO-1310 | DRUG | ATTO-1310 Attobody |
| ATTO-1310 Placebo | DRUG | Placebo preparation to match ATTO-1310 Dose |
Parts 1 \& 2 (Healthy Volunteers) Key Inclusion Criteria: * Any sex or gender who is 18 to 65 years old * Body weight of 50 to 125 kg and body mass index (BMI) between 18.5 and 35 kg/m2 * Considered in good general health based on medical history, physical exam, 12-lead ECG, screening clinical labo...
ATTO-1310 is an investigational small molecule being developed for dermatology conditions. It is currently being studied in healthy volunteers, as well as in patients with atopic dermatitis (atopic eczema) and chronic pruritus. The drug is in Phase 1 clinical development and is not yet approved by the FDA.
ATTO-1310 is being developed by Alamar Biosciences, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol ALMR. The company is conducting clinical trials to evaluate the safety, tolerability, and pharmacokinetics of this investigational drug.
ATTO-1310 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is active but not recruiting participants, and it is designed to assess the safety, tolerability, and pharmacokinetics of the drug.
ATTO-1310 is being evaluated in a Phase 1 clinical trial registered as NCT06787586. This study is titled "Safety, Tolerability and PK of ATTO-1310 in Healthy Volunteers and Patients With Atopic Dermatitis and Patients With Chronic Pruritus." The trial is active but not recruiting, with an enrollment of 108 participants across the United States and Canada.
Yes, the Phase 1 clinical trial of ATTO-1310 is randomized, double-blind, and placebo-controlled. This means participants are randomly assigned to receive either the active drug or a placebo, and neither the participants nor the researchers know who receives which treatment during the study.
The molecular target of ATTO-1310 has not been disclosed in the available information. The drug is a small molecule being investigated for its effects in dermatological conditions, but its specific mechanism of action is not publicly detailed at this time.